[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Notices]
[Pages 21248-21249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08846]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Addressing Inadequate Information on Important Health Factors in
Pharmacoepidemiology Studies Relying on Healthcare Databases; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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The Food and Drug Administration (FDA) is announcing a public
workshop, cosponsored by FDA and the University of Maryland Center for
Excellence in Regulatory Science and Innovation, entitled
``Methodological Considerations to Address Unmeasured Information About
Important Health Factors in Pharmacoepidemiology Studies that Rely on
Electronic Healthcare Databases to Evaluate the Safety of Regulated
Pharmaceutical Products in the Postapproval Setting.'' The purpose of
the public workshop is to engage in constructive dialogue among
regulators, academicians, pharmaceutical industry, clinicians, other
stakeholders and the general public on potential strategies to improve
availability of information on important health factors in
pharmacoepidemiology studies that rely on electronic healthcare
databases to evaluate the safety of pharmaceutical products in the
postapproval setting. Electronic healthcare databases are increasingly
being used in the postapproval assessment of the safety profile of
pharmaceutical drug products.
Date and Time: The public workshop will be held on May 4, 2015, 8
a.m. to 5 p.m.
Location: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
workshop participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact Person: Leslie Wheelock, Office of the Commissioner, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4345,
Silver Spring, MD, 301-796-4580, FAX: 301-847-8106,
[email protected].
Registration: Submit your online registration information
(including name, title, firm name, address, telephone and fax numbers)
by April 30, 2015, at: http://www.pharmacy.umaryland.edu/centers/cersievents/biasinbigdata/. There is no registration fee for University
of Maryland faculty, students, and staff, University of Maryland Center
for Excellence in Regulatory Science and Innovation Industrial
Consortia Members, and Federal Government employees. There is a $50.00
registration fee for all other participants. Early registration is
recommended because seating is limited. There will be no onsite
registration.
If you need special accommodations due to a disability, please
contact Leslie Wheelock (see Contact Person) at least 7 days in
advance.
SUPPLEMENTARY INFORMATION:
In many instances, these resources allow for the timely evaluation
of drug-related adverse events since data on healthcare utilized by a
large number of individuals are readily available. However, because
these data are typically collected for administrative purposes,
information on important health factors necessary to evaluate drug-
outcome relationship may be
[[Page 21249]]
absent or incomplete in these data sources. Examples include tobacco/
smoking use and history, alcohol consumption, weight and height,
patient and family medical history, or use of over-the-counter
medications. Incomplete capture or the absence of this information can
result in biased or uncertain estimates for the drug-outcome
relationship of interest leading to inadequate evaluation of the safety
profile of prescription drug products.
Webcast: Please be advised that as soon as possible after a Webcast
of the public workshop is available, it will be accessible at: http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm429136.htm.
Dated: April 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08846 Filed 4-16-15; 8:45 am]
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